Trevo 90182Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00815742001822), received between Jun 27, 2018 and Nov 21, 2025 — classified as 1 death, 23 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K132641, K203219); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 23, 2024Open, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1902-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN INTRACRANIAL MIDDLE CAROTID ARTERY (MCA) THROMBECTOMY PROCEDURE, THE OPERATOR PREPARED TO USE THE SUBJECT STENT RETRIEVER FOR THROMBECTOMY. AFTER DELIVERING THE MICROCATHETER TO THE TARGET SITE, THE OPERATOR STARTED TO ADVANCE THE SUBJECT STENT RETRIEVER. HOWEVER, IT ENCOUNTERED RESISTANCE UPON ENTERING THE MICROCATHETER, AND THE RESISTANCE INCREASED AS THE SUBJECT STENT RETRIEVER ADVANCED FURTHER. THE SUBJECT STENT RETRIEVER WAS DELIVERED TO THE TARGET LESION AND DEPLOYED. AFTER WAITING FOR APPROXIMATELY 5 MINUTES, THE OPERATOR ATTEMPTED TO RETRACT THE SUBJECT STENT RETRIEVER, BUT IT COULD NOT BE PULLED BACK AND BECAME STUCK IN THE VESSEL. THUS, THE OPERATOR ADVANCED THE ASPIRATION CATHETER PAST HALF OF THE STENT RETRIEVER AND WAS ABLE TO RETRACT IT INTO THE CATHETER EXPERIENCING SIGNIFICANT RESISTANCE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621921 ↗
• InjuryMay 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT RETRIEVER WAS BROKEN INSIDE THE CLOT. IT WAS LEFT INSIDE THE PATIENT'S M2 VESSEL. THE PATIENT'S ANATOMY WAS REPORTED TO BE SEVERELY TORTUOUS. THERE WAS UNKNOWN LENGTH OF SURGICAL DELAY REPORTED AND THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11859569 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE, THE SUBJECT RETRIEVER WAS ADVANCED TO THE TARGET SITE AND THE STENT WAS NOTED TO BE TWISTED AT THE PROXIMAL END WHEN DEPLOYED UNDER THE X-RAY IMAGING. WHEN THE PHYSICIAN WITHDREW THE RETRIEVER OUT OF THE PATIENT¿S ANATOMY, AND THE PROXIMAL END OF THE RETRIEVER WAS FOUND SEPARATED. ALL BROKEN PART OF THE RETRIEVER WAS REMOVED FROM THE PATIENT¿S ANATOMY. ANOTHER RETRIEVER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT CONDITION WAS GOOD, AND NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620032 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBECTOMY IN THE BASILAR WAS PERFORMED AND SUBJECT RETRIEVER WAS USED FOR PROCEDURE. PATIENT MRS (MODIFIED RANKIN SCALE) SCORE BEFORE ONSET WAS NOTED TO BE 3 AND ASPECTS (ALBERTA STROKE PROGRAM EARLY CT SCORE) WAS 10. AFTER THE FIRST PASS PERFORMED WITH SUBJECT DEVICE, MTICI (MODIFIED TREATMENT IN CEREBRAL ISCHEMIA) INCREASED FROM 0 TO 2B TEMPORARILY BUT FINAL MTICI RETURNED TO 0. VESSEL DISSECTION AND VESSEL PERFORATION OCCURRED DURING PROCEDURE. VESSEL DISSECTION WAS ALLEGEDLY RELATED TO THE SUBJECT STENT RETRIEVER, WHEREAS VESSEL PERFORATION WAS NOT RELATED TO THE SUBJECT STENT RETRIEVER. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING PROCEDURE. 7 DAYS POST PROCEDURE, MRS WAS 6 AND THE PATIENT PASSED AWAY DUE TO SUBARACHNOID HEMORRHAGE (SAH) WHICH HAD DEVELOPED BEFORE THE PROCEDURE AND CAUSED BASILAR INFARCTION. IN THE PHYSICIAN¿S OPINION, THE PATIENT¿S DEATH WAS CAUSED BY WORSENING OF THE DISEASE (CEREBRAL INFARCTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 11060733 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT DEVICE RETRIEVER WAS USED TO REMOVE THE PROXIMAL FACE OF CLOT LOCATED AT THE RIGHT ICA (INTERNAL CAROTID ARTERY) CERVICAL (NOT T). PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 0 AND NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 0. IT WAS REPORTED THAT DURING PROCEDURE, SAH (SUBARACHNOID HEMORRHAGE) OCCURRED AND STENT PLACEMENT WAS PERFORMED TO TREAT SAH. WITHIN 24 HOURS AFTER THE PROCEDURE SHOWED TICI OF 2B67 AND NIHSS OF 16. FOLLOW-UP WITH CT (COMPUTED TOMOGRAPHY) SCAN AFTER THE STUDY PROCEDURE TO 48 HRS POST PROCEDURE REVEALED SAH (SUBARACHNOID HEMORRHAGE) IN THE LEFT SYLVIAN FISSURE. THIS WAS ASYMPTOMATIC AND STABLE IN THE FOLLOW UP CT SCAN LATER. MEDICAL MANAGEMENT WAS ADMINISTERED IN RESPONSE TO THE PATIENT HEMORRHAGE AND THE PATIENT WAS DISCHARGED APPROXIMATELY 5-7 DAYS POST PROCEDURE WITH NIHSS OF 18 AND MRS (MODIFIED RANKIN SCORE) OF 4. PER PHYSICIAN¿S OPINION STATED THAT WHEN USING THE SUBJECT RETRIEVER MULTIPLE TIMES IN SMALLER VESSELS LIKE M2, IT IS COMMON TO SEE SAH AROUND THE TARGET VESSEL. IT DOES NOT CAUSE SYMPTOM. NO OTHER INFORMATION WAS PROVIDED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10938406 ↗
• InjuryDec 1, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove

  THE PATIENT PRESENTED TO THE HOSPITAL WITH A CLOT ON THE SUPERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY (DISTAL M1 SEGMENT). DURING THE FIRST ATTEMPT USING THE RETRIEVER, THE SUBJECT RETRIEVER WAS STUCK WHEN THE PHYSICIAN TRIED TO PULL IT OUT AND WAS NOTED TO BE BROKEN. THE PHYSICIAN WAS NOT ABLE TO REMOVE ALL PARTS OF THE BROKEN RETRIEVER. THE DETACHED PART OF THE RETRIEVER WAS LEFT IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT SUFFERED FROM HEMISPHERIC STROKE ON THE RIGHT.

  Patient problems: Foreign Body In Patient; Ischemia Stroke

  MAUDE report 10925799 ↗
• MalfunctionNov 18, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE OF THROMBECTOMY FOR LEFT M1-DISTAL, WITH MRS SCORE OF THE PATIENT BEFORE THE ONSET WAS 1, REMOVAL DIFFICULTY OF RETRIEVER (SUBJECT DEVICE) WHILE RETRIEVING THE CLOT ALONG WITH RETRIEVER FROM THE VESSEL INTO THE CATHETER OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO VESSEL PERFORATION, VESSEL DISSECTION OR HEMORRHAGE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10865682 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING STUDY PROCEDURE, THE SUBJECT DEVICE RETRIEVER WAS USED TO REMOVE THE PROXIMAL FACE OF CLOT, LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 24 AND MRS (MODIFIED RANKIN SCORE) OF 0. IT WAS REPORTED THAT THE ENT (EMBOLIZATION TO NEW TERRITORY) OCCURRED IN THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA; THEREFORE, THE SECOND PASS OF THROMBECTOMY WAS PERFORMED TO TREAT ENT. THERE WERE NO SERIOUS ADVERSE EVENT OR NEUROLOGICAL DETERIORATION REPORTED DUE TO THE ENT. THE EVENT WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 24 HOURS POST PROCEDURE, THE PATIENT¿S NEUROLOGICAL ASSESSMENT SHOWED TICI OF 3. THE PATIENT WAS DISCHARGED ON DAY 5-7 WITH NIHSS OF 4. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 10789772 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 PASS WAS PERFORMED USING THE SUBJECT DEVICE RETRIEVER AND ASPIRATION CATHETER FOR CARDIO EMBOLIC DEVELOPED ON THE LEFT M2. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 1 AND MRS (MODIFIED RANKIN SCORE) OF 4. THE PROCEDURE WAS COMPLETED WITH TICI OF 2B AND MRS OF 6. APPROXIMATELY ONE DAY POST PROCEDURE, THE PATIENT CT (COMPUTED TOMOGRAPHY) SCAN AND MRI (MAGNETIC RESONANCE IMAGING) SHOWED THE CEREBRAL HEMORRHAGE (PH-2), SYMPTOMATIC INTRACRANIAL HEMORRHAGE AND SAH (SUBARACHNOID HEMORRHAGE). IT IS UNKNOWN IF THE HEMORRHAGE WAS TREATED. IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOURTEEN DAYS POST PROCEDURE AND THE CAUSE OF THE DEATH IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. UPDATE INFORMATION: RECEIVED ADDITIONAL INFORMATION ON 10-NOV-2020 INDICATED THAT THE PATIENT DEATH WAS CAUSED BY THE PATIENT¿S PREEXISTING CONDITION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10771749 ↗
• MalfunctionOct 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN PULLED THE SUBJECT RETRIEVER INTO A CATHETER TO REMOVE BOTH DEVICES FROM THE PATIENT. WHEN THE DELIVERY WIRE OF THE SUBJECT RETRIEVER CAME OUT OF THE CATHETER, THE STENT WASN'T ATTACHED TO IT. PHYSICIAN FLUSHED THE CATHETER AND THE STENT OF SUBJECT STENT RETRIEVER CAME OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756721 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE WITH THE SUBJECT STENT RETRIEVER, PATIENT VESSEL PERFORATION AND DISSECTION OCCURRED. PHYSICIAN WAS UNABLE TO CONFIRM IF THE SUBJECT DEVICE WAS RESPONSIBLE FOR THE PATIENT VESSEL PERFORATION AND DISSECTION. HEPARIN AND WARFARIN WERE REVERSED TO TREAT THE VESSEL PERFORATION AND DISSECTION AND BLEEDING STOPPED. ASPIRATION WAS DONE WITH A CATHETER AND PROCEDURE WAS COMPLETED SUCCESSFULLY. ONE DAY POST OPERATION, THE PATIENT DEVELOPED INTERCRANIAL HEMORRHAGE (ICH) AND SYMPTOMATIC SUB ARACHNOID HEMORRHAGE (SAH). TREATMENT FOR ICH AND SAH IS UNKNOWN. PATIENT WAS TRANSFERRED TO A REHABILITATION HOSPITAL FOR FURTHER MANAGEMENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels; Vascular Dissection

  MAUDE report 10668078 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT RETRIEVER WAS USED DURING THROMBECTOMY PROCEDURE FOR A CLOT IN THE LEFT M2 BRANCH ON (B)(6) 2020 AND VESSEL DISSECTION OCCURRED RELATED TO THE SUBJECT RETRIEVER. 2 PASSES WERE PERFORMED USING THE SUBJECT RETRIEVER AND 1 PASS WAS PERFORMED USING NON-STRYKER RETRIEVER. THE FINAL TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 2B. HEMORRHAGE WAS NOT OBSERVED IN THE MIR SCAN 24 HOURS POST PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 10636856 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT DEVICE RETRIEVER WAS USED TO REMOVE THE PROXIMAL FACE OF CLOT, LEFT ANTERIOR CEREBRAL ARTERY (ACA) A1 EXTENDING TO A2. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 2A, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 16 AND MRS (MODIFIED RANKIN SCORE) OF 0. IT WAS REPORTED THAT THE ENT (EMBOLIZATION TO NEW TERRITORY) WAS OBSERVED DURING PROCEDURE ON THE LEFT MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT. THE ENT WAS TREATED WITH FIRST PASS AND TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF GRADE 3 WAS ACHIEVED. THERE WERE NO SERIOUS ADVERSE EVENT OR NEUROLOGICAL DETERIORATION REPORTED DUE TO THE ENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT¿S NEUROLOGICAL ASSESSMENT SHOWED NIHSS OF 15 AFTER 24 HOURS PROCEDURE. THE PATIENT WAS DISCHARGED ON DAY 5-7 WITH NIHSS OF 4 AND MRS OF 3. ON DAY 30 WITH THE MRS OF 2. NO OTHER INFORMATION WAS PROVIDED. UPDATE ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED ON 12/14/2020 INDICATED THAT THE PATIENT WAS AFFECTED BY TANDEM OCCLUSION CHARACTERIZED BY LEFT FLOATING CLOT AT INTERNAL CAROTID ARTERY CAUSING SEVERE STENOSI

  Patient problems: Embolism/Embolus

  MAUDE report 10539150 ↗
• InjuryAug 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE M1 SEGMENT OF LEFT MIDDLE CEREBRAL ARTERY, THE SUBJECT STENT WAS USED TO RETRIEVE THE CLOT. THE PHYSICIAN PULLED THE SUBJECT STENT RETRIEVER, BUT IT BROKE OFF FROM THE DELIVERY WIRE DURING RETRACTION. SUBJECT STENT RETRIEVER WAS STUCK INSIDE PATIENT AND NO ATTEMPTS WERE MADE TO REMOVE IT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. PATIENT IS CURRENTLY ON BLOOD THINNER MEDICATION AND ASPIRIN. PATIENT IS CURRENTLY RECOVERING FROM PROCEDURE IN THE INTENSIVE CARE UNIT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10367623 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STUDY PROCEDURE WITH THE SUBJECT DEVICE (RETRIEVER), THE DISTAL OCCLUSION IN ACA TERRITORY (A1) AND NEW ENT (EMBOLIZATION TO NEW TERRITORY) TO A2 WERE OCCURRED. THE ADVERSE EVENTS WERE TREATED BY RECANALIZATION/THROMBECTOMY. THE PROCEDURE WAS COMPLETED, AND THE EVENTS WERE RESOLVED WITH TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 2A WAS ACHIEVED. IT¿S INDICATED THAT THERE WAS RELATIONSHIP BETWEEN THE ADVERSE EVENTS TO THE INDEX STROKE, INDEX PROCEDURE AND THE TECHNIQUE WAS NOT SUCCESSFUL DUE TO SUBJECT DEVICE (RETRIEVER) DEPLOYMENT FAILURE. NO OTHER INFORMATION WAS PROVIDED. UPDATED INFORMATION: RECEIVED ADDITIONAL INFORMATION ON 9/4/2020 INDICATED THAT THE THE DISTAL OCCLUSION WAS CAUSED BY IATROGENIC EMBOLIZATION DURING PROCEDURE AND TORTUOUS ANATOMY.

  Patient problems: Embolism/Embolus; Embolus; Occlusion; Thromboembolism

  MAUDE report 10336163 ↗
• InjuryJul 19, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE STUDY PROCEDURE, THE INTRACRANIAL CAROTID DISSECTION WAS OCCURRED. THEREFORE, STENTING OF CAROTID DISSECTION WAS PERFORMED ALONG WITH MEDICAL MANAGEMENT IN RESPONSE TO THE PATIENT¿S DISSECTION. THE PROCEDURE WAS COMPLETED, AND THE EVENT WAS RESOLVED WITH THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF GRADE 2A. THE PATIENT WAS DISCHARGED WITH INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 13. IT¿S INDICATED THAT THERE WAS RELATIONSHIP BETWEEN THE EVENT TO THE SUBJECT DEVICE (RETRIEVER) AND INDEX PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 10293836 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT OF CARDIOGENIC CEREBRAL EMBOLISM, THE SUBJECT RETRIEVER AND ASPIRATION CATHETER WERE USED TO REMOVE THE THROMBOSIS. THE PATIENT MRS (MODIFIED RANKIN SCALE) PRE PROCEDURE OF 2 AND IMMEDIATELY AFTER PASS MTICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE OF 1 WAS ACHIEVED. IT WAS REPORTED THAT SYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED AFTER PROCEDURE AND WAS ASSESSED HAVING A MRS OF 5. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10059743 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 28-APRIL-2020 INDICATED THAT VASOSPASM OCCURRED AND REQUIRING MEDICATION DURING USE OF THE SUBJECT DEVICE (RETRIEVER). THE MEDICATION WAS ADMINISTERED, AND THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED. ACCORDING TO THE SITE, THE RELATIONSHIP OF THE VASOSPASM TO THE SUBJECT DEVICE (RETRIEVER), THE DISTAL ACCESS CATHETER, THE BALLOON CATHETER AND TO THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Vasoconstriction

  MAUDE report 10023196 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE AT THE BASILAR ARTERY, FIRST PASS WAS PERFORMED WITH THE SUBJECT RETRIEVER AND SECOND PASS WAS PERFORMED WITH ANOTHER COMPANY'S STENT RETRIEVER. THE NEXT DAY POST PROCEDURE, COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND INTRACRANIAL HEMORRHAGE WAS NOTED INSIDE THE PATIENT'S ANATOMY. THE MEDICAL TREATMENT GIVEN TO THE PATIENT IS UNKNOWN. THE PHYSICIAN CONFIRMED THAT THE SUBJECT RETRIEVER PERFORMED AS INTENDED DURING THE PROCEDURE AND THE REASON FOR THE INTRACRANIAL HEMORRHAGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 9806598 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A SUCCESSFUL THROMBECTOMY PROCEDURE PERFORMED AT THE BASILAR ARTERY, INTRACRANIAL HEMORRHAGE WAS OBSERVED INSIDE THE PATIENT¿S ANATOMY WITHIN 24 HOURS AFTER THE PROCEDURE. THE SUBJECT RETRIEVER WAS USED DURING THE PROCEDURE. IN THE PHYSICIAN¿S OPINION, THE SUBJECT RETRIEVER PERFORMED AS INTENDED DURING THE PROCEDURE AND THE REPORTED ADVERSE EVENT WAS RELATED TO PATIENT¿S PRE-EXISTING CONDITION. NO ADDITIONAL CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: Intracranial Hemorrhage; No Consequences Or Impact To Patient

  MAUDE report 9795440 ↗
• DeathMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMBECTOMY FOR CARDIO EMBOLIC OF LEFT INTERNAL CAROTID ARTERY(ICA), TERMINUS BIFURCATION WAS DONE WITH THE SUBJECT RETRIEVER AND ASPIRATION CATHETER AND SUCCESSFUL RECANALIZATION WAS CONFIRMED DURING THE PROCEDURE. A FEW DAYS LATER, SYMPTOMATIC INTRACRANIAL HEMORRHAGE WAS CONFIRMED IN THE PATIENT AND LATER THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S OPINION, SUBJECT RETRIEVER PERFORMED AS INTENDED DURING THE PROCEDURE, THE CAUSE FOR THE INTRACRANIAL HEMORRHAGE WAS BLEEDING DUE TO THE OPENING OF THE INFARCTED AREA, AND THE CAUSE OF THE PATIENT DEATH WAS WORSENING OF PRIMARY DISEASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 9781395 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SUBARACHNOID HEMORRHAGE (SAH) AFTER THE STUDY PROCEDURE TO 48 HOURS POST PROCEDURE. THE BRAIN CT (COMPUTED TOMOGRAPHY) SCAN DISCLOSED HYPODENSITY WITHIN THE LEFT FRONTAL AND PARIETAL SUBARACHNOID SPACE. THE EVENT DID NOT LEAD TO ANY NEUROLOGIC DETERIORATION OF THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE. UPDATE ADDITIONAL INFORMATION RECEIVED ON 03-FEB-2020 ADDITIONAL INFORMATION STATED THAT THE PATIENT WAS PRESENTED WITH NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) SCORE OF 5 AND BASELINE MODIFIED RANKIN SCALE (MRS) SCORE OF 0. THE SUBARACHNOID HEMORRHAGE WAS BASED ON IMAGING FINDING ¿BRAIN CT (COMPUTED TOMOGRAPHY): HYPODENSITY WITHIN THE LEFT FRONTAL AND PARIETAL SUBARACHNOID SPACE¿. THE PATIENT HEMORRHAGE WAS RESOLVED ON ITS OWN NEXT DAY AND IT WAS REPORTED AS NON-SERIOUS ADVERSE EVENT. THE SUBARACHNOID HEMORRHAGE POSSIBLY RELATED TO THE SUBJECT DEVICE RETRIEVER BUT UNCLEAR. NO ACTIVE EXTRAVASATION WAS SEEN, SO COULD HAVE HAPPENED DURING WIRE OR CATHETER ACCESS OR AFTER STENT DEPLOYMENT OR RETRIEVAL. ACCORDING TO THE PHYSICIAN, THERE WAS NO ALLEGATION ALLEGED AGAINST THE SUBJECT DEVICE RETRIEVER. THE PROCEDURE WAS COMPLE

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 9501288 ↗
• InjuryMay 20, 2019Break; Break

  IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS DELIVERED TO THE LESION IN THE MIDDLE CEREBRAL ARTERY (MCA) FOR ENDOVASCULAR ISCHEMIC STROKE THROMBECTOMY CASE. AFTER THE CLOT WAS CAPTURED, THE PHYSICIAN PULLED BACK THE DELIVERY WIRE ASSUMING THE SUBJECT STENT WOULD FOLLOW AS WELL; HOWEVER, THE SUBJECT STENT WAS LEFT INSIDE THE RIGHT MCA REACHING OUT FROM INTERNAL CAROTID ARTERY (ICA) DISTAL AS IT BROKEN OFF FROM THE DELIVERY WIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING GOOD FOR THE FIRST TWO DAYS AFTER THE PROCEDURE, THEN HIS CONDITION WORSENED. THE PHYSICIAN BELIEVES THAT THE PATIENT IS NOW RIGHT HEMIPLEGIC DUE TO THE BROKEN STENT RETRIEVER.

  Patient problems: Device Embedded In Tissue or Plaque; Neurological Deficit/Dysfunction

  MAUDE report 8624748 ↗
• InjuryApr 16, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE FOR AN IC(INTERNAL CAROTID) OCCLUSION, THE RETRIEVER (SUBJECT DEVICE) WAS DEPLOYED FROM M1 TO DISTAL M2 AT A CONFIRMED OCCLUSION OF M1 DISTAL (MIDDLE CEREBRAL ARTERY). THE PHYSICIAN WAS NOT ABLE TO REMOVE THE RETRIEVER FROM THE VESSEL, THE DEVICE CUT INTO THE VESSEL AND THE STENT PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY. THE PHYSICIAN PERFORMED A CRANIOTOMY TO REMOVE THE LODGED STENT PORTION, BUT WAS UNSUCCESSFUL AND SUBSEQUENTLY STOPPED THE PROCEDURE. CLIPPING WAS PERFORMED THE FOLLOWING DAY AND IT WAS REPORTED THAT THE PRESENTING CONDITION OF IC INFARCTION WORSENED AFTER PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 8520628 ↗
• InjuryApr 9, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING THE THROMBECTOMY PROCEDURE OF THE MIDDLE CEREBRAL ARTERY (MCA), THE STENT RETRIEVER (SUBJECT DEVICE) COULD NOT BE WITHDRAWN FROM THE PATIENT VESSEL. THE REPORTED EVENT REQUIRED AN ASPIRATION CATHETER TO REMOVE THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8498129 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132641, K203219. One submission often covers many models, so check the product and lot details in each record.

• Z-0347-2018 · Nov 28, 2017 · Terminated
  Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
• Z-0276-2018 · Nov 3, 2017 · Terminated
  Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Acc
• Z-0275-2018 · Nov 3, 2017 · Terminated
  Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.0
• Z-0277-2018 · Nov 3, 2017 · Terminated
  Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention